Translating Clinical Outcome Assessments (COAs) for a research study requires careful preparation and review. If you are familiar with the process of creating and validating a measurement instrument in one language, you can appreciate the complexities of translating it into another language. In addition, Internal Review Boards and/or regulatory agencies will require documentation establishing that all efforts were made to translate and validate multilingual instruments.

We translate and localize medical and pharma content for multilingual research. Find out how we can help you.

The translation and validation process can take up to 12 weeks. To avoid delays, a clear workflow must be established and the roles of all participants communicated clearly. Here is a synopsis of the process and procedures we follow for translation of COAs for patients (PROs), clinicians (ClinROs), observers (ObsROs), and performers (PerfOs).

Identifying the needs of the target population

  • What are the demographic characteristics of the target population? Should the instrument be designed to be widely understood by all speakers of the target language, or will it be tailored to a particular region or country?  This is relevant because people speak different dialects of English, Spanish, French, Arabic, and other languages around the world.
  • Will an interviewer be asking the questions verbally, or will the subjects read the questions and write the answers?  While translators will always strive for simplicity of language, they’ll want to know if they should be writing for a particular level of literacy.

Establishing the internal review team

  • Carefully choose and educate the members of your internal review team at the start of the project. Internal review is the point at which projects are most at risk for unacceptable delays. Avoid delays by choosing the reviewers carefully and engaging them early in the process.  We have written elsewhere about how to avoid internal review delays. To summarize:
  • Choose reviewers with the appropriate language ability. Even if a reviewer is a native speaker of the target language, he or she may not be familiar with the target dialect (for example, a native European Portuguese speaker will speak and write differently than a Brazilian Portuguese speaker).
  • Choose reviewers with relevant subject matter expertise.
  • Choose reviewers who have the time, motivation, and temperament to give adequate attention to the materials and collaborate productively with the rest of the team.
  • Be clear about the reviewer’s role. The reviewer’s job is not to “make it better.” Reviewers should only flag issues where the language is truly confusing or inaccurate. The reviewer should know the difference between substantive and preferential changes. Preferential changes will bog down the process significantly: because they are matters of opinion, they are hard to resolve.

Conceptual analysis and translation

  • Before beginning the translation, the English source requires conceptual analysis by a bilingual cultural consultant who has deep familiarity with the culture of the target population. Items, terms, and concepts that might be unfamiliar or confusing will be flagged for discussion and clarification. At this point, a conversation between the internal review team and the translation team will help clarify the meaning within the context and goals of the questionnaire. If reviewers are members of the target population, this is their opportunity to weigh in on the basics before the translation process begins. Notes of clarification should be included in the source to provide context for the translator.
  • Once an adjusted and annotated source document is available, a publication-ready translation will be produced. This includes translation by a native-language professional linguist, bilingual review by a second native-language linguist, and in-house QA.  If required, more than one “forward” translation can be created. These will be reviewed and reconciled during linguistic validation.

Linguistic validation

  • At this point, the review team will engage in linguistic validation of the translated instrument. If there are problems, these need to be discussed and resolved.
  • As mentioned above, the role of the review team is to confirm that the meaning of each item is clear. A reviewer should not try to “improve” the writing. Suggested changes should be limited to issues related to:
    • Consistency of meaning between the source and target instruments
    • Words or expressions that may be confusing or inappropriate.
  • Every suggested correction should include a note to the translator explaining why the wording will obstruct the subject’s understanding of the question, and how it can be fixed.
  • Changes recommended by the review team will be incorporated by the translation team to create a finalized translation.

Conceptual validation

  • Back translation is used for conceptual and cultural validation of the translation. A native English-speaking independent professional translator who has no knowledge of the original source document will “back-translate” the finalized translation into English.
  • The purpose of the back translation is to establish conceptual equivalence, not linguistic equivalence. If substantial differences of meaning between the original source text and the back translation are identified, these must be discussed and reconciled. This may require meetings between the translator, back-translator, and reviewers.
  • Some studies require not one but two independent back translations followed by reconciliation. The two back translations must be conceptually equivalent, not linguistically identical.

Pre-testing and cognitive review

  • The translated instrument will be pre-tested with individuals who are representative of the target population. Each subject will be asked to repeat the question in their own words and explain what they think the question is asking and how they decided on their response. If certain elements are consistently confusing or misleading, they will be flagged for review. These debriefing sessions will be closely documented (ideally, recorded and transcribed) and the findings reported to the review committee.

Finalizing the questionnaire

  • If pre-testing indicates that significant changes are required, a second back-translation and reconciliation session may be warranted.  However, if everyone is brought into the loop and kept apprised of the process as it unfolds, and the translation team and reviewers are familiar with the needs of the target population, changes at this point will probably not be necessary.

Documentation should include

  • The initial forward translation
  • A summary of recommendations by the review team
  • The back-translation(s)
  • A summary of any modifications proposed during pre-testing
  • A linguistic validation certificate if required.
  • Any other requirements specific to the IRB or regulatory agency.

Variations on this process are suitable for translating questionnaires, surveys, and informed consent forms. Similar procedures are also followed when translating for medical devices and pharmaceuticals, for example IFUs (Instructions for Use) and any other materials requiring the highest level of accuracy.  If you have questions about translation for clinical research trials, please contact us.

Do you need translation for clinical research studies? Contact us for information on process and pricing.